BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX PANEL NMIC-306

    MDR report key: 19484151 · Received June 7, 2024

    Report

    Report Number
    1119779-2024-00491
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 9, 2024
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    LON
    UDI-DI
    00382904492922
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G5. PMA / 510(K)#: K020322, K022129, K023444, K023634, K023858, K024153, K031530, K031699, K031912, K032299, K032567, K032655, K033362, K033560, K041384, K042932, K052269, K060214, K060217, K060257, K060444, K060447, K061327, K061355, K062207, K062944, K063301, K063486, K063573, K063811, K063824, K071623, K132674, K132909, K151320, K181665, K173252, K190905, K163637, K173523, K033458, AND K123266. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT IS FOR HIGH MIC ERTAPENEM (ETP) WITH KLEBSIELLA PNEUMONIAE AND ESCHERICHIA COLI WHEN USING PHOENIX PANEL NMIC-306 (CATALOG NUMBER 449292) BATCH NUMBER 4072423. THE CUSTOMER RETURNED ISOLATES BUT DID NOT RETURN PANELS FOR THE INVESTIGATION. TO INVESTIGATE, RETENTION PANELS OF THE COMPLAINT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE HCCL-1, E. COLI HCCL-2, AND K. PNEUMONIAE HCCL-3 AND PLACED A PHOENIX M50 MACHINE TO EVALUATE FOR ETP MIC RESULTS. ALSO, CONTROL PANELS FROM THE SAME MATERIAL BUT DIFFERENT BATCH WERE INOCULATED WITH CUSTOMER RETURNED ISOLATES K. PNEUMONIAE HCCL-1, E. COLI HCCL-2, AND K. PNEUMONIAE HCCL-3 AND PLACED A PHOENIX M50 MACHINE TO EVALUATE FOR ETP MIC RESULTS. ALL PANELS TESTED RETURNED THE EXPECTED MIC RESULTS FOR ETP WITH THEIR RESPECTIVE ISOLATES. THIS COMPLAINT IS NOT CONFIRMED. THE BATCH HISTORY RECORD WAS SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. BD WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING BD PHOENIX PANEL NMIC-306, THERE WAS A FALSE RESISTANT RESULT FOR ERTAPENEM. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 A HIGH MIC WAS REPORTED THREE (3) TIMES FOR THE DRUG ERTAPENEM FROM DIFFERENT ISOLATES SOURCES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PHOENIX PANEL NMIC-306 A HIGH MIC WAS REPORTED THREE (3) TIMES FOR THE DRUG ERTAPENEM FROM DIFFERENT ISOLATES SOURCES. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHOENIX PANEL NMIC-306, THERE WAS A FALSE RESISTANT RESULT FOR ERTAPENEM. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581073 BD PHOENIX PANEL NMIC-306 SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY LON BECTON DICKINSON & CO. (SPARKS) 4072423 00382904492922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown